Study of Intradermal Administration of PCEC Rabies Vaccine (Rabies-ID)

A Single Center, Open-Label, Study of Intradermal Administration of an Inactivated PCEC Rabies Vaccine in Adult Subjects

The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.

Study Overview

• Status: Completed
• Conditions: Rabies Prevention; Rabies Exposure
• Intervention / Treatment: Biological: PCEC rabies vaccine given intradermally; Biological: PCEC rabies vaccine administered intramuscularly

Detailed Description

Approximately 16,000-39,000 persons come in contact with potentially rabid animals and receive rabies postexposure prophylaxis (PEP) each year in the US. To appropriately manage potential human exposures to rabies, the risk for infection must be accurately assessed. Administration of rabies PEP is a medical urgency, not a medical emergency, but decisions must not be delayed. Prophylaxis is occasionally complicated by adverse reactions, but these reactions are rarely severe. Current data on the safety and efficacy of active and passive rabies vaccination were derived from both human and animal studies. Timely and appropriate human pre-exposure prophylaxis (Pre-EP) and PEP will prevent human rabies. Currently in the US, the approved dosage and administration for PEP in previously unvaccinated persons consists of the administration of vaccine (HDCV or PCECV) and HRIG. Vaccine is administered IM on days 0, 3, 7, 21, and 28 (deltoid area). The approved dosage and administration for pre-exposure prophylaxis (Pre-EP) consists of three 1.0-mL injections of vaccine (HDCV or PCECV) administered IM (deltoid area), one injection per day on days 0, 7, and 21 or 28). Intradermal (ID) route of administration of rabies vaccination is used in certain countries both for PEP and Pre-EP, and approved by WHO for modern potent cell culture vaccines. Recent studies outside the USA found the use of PCEC rabies vaccine by ID administration immunogenic and safe.

The primary goals of this study are to obtain additional safety and immunogenicity data on ID administration of 0.1 mL doses of the inactivated PCEC rabies virus vaccine in adults. Given the need to provide alternative routes of administration to the current approved intramuscular route in order to protect a larger number of people facing potential vaccine shortages. The data yielded by this clinical trial will provide evidence to support alternative route of administration and dose of PCECV in the US.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30333
      • CDC Occupational Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study.
2. Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older.
3. Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period.
4. Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
5. Able to understand and comply with planned study procedures.
6. Provide informed consent prior to any study procedures and be available for all study visits.
7. Have health insurance.

Exclusion Criteria:

1. Have a known allergy to PCECV.
2. Have a known allergy or sensitivity to eggs or latex (in the stopper).
3. Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age).
4. Are immunosuppressed as a result of an underlying illness or treatment.
5. Have active neoplastic disease or a history of any hematologic malignancy.
6. Are using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
7. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
8. Have an acute illness that is accompanied by an oral temperature greater than 100.4°F, within 1 week of vaccination.
9. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 1st month of the study period.
10. Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
11. He/she is a CDC worker under direct supervision of any of the primary study investigators (Dr. Sergio Recuenco, and Dr. Eli Warnock).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: Pre-EP ID; Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.	Biological: PCEC rabies vaccine given intradermally; PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.; Other Names: RabAvert
Active Comparator: 2: Pre-EP IM; Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.	Biological: PCEC rabies vaccine administered intramuscularly; PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.; Other Names: RabAvert
Experimental: 3: Booster ID; Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.	Biological: PCEC rabies vaccine given intradermally; PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.; Other Names: RabAvert
Active Comparator: 4: Booster IM; Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.	Biological: PCEC rabies vaccine administered intramuscularly; PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.; Other Names: RabAvert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT, 14 days after receipt of the last dose of the vaccine.	Proportion of subjects achieving rabies virus-neutralizing antibody titers ≥1:5 as measured by the rapid fluorescent focus inhibition test (RFFIT).	14 days after receipt of the last dose of the vaccine.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).	Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) following vaccination, assessed through clinical evaluation and subject-reported outcomes.	Imnediately after fisrt dose to completion of the study 6 months later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who have virus-neutralizing antibody titers of at least 1:5 serum dilution by the RFFIT in each group.	Proportion of subjects achieving rabies virus-neutralizing antibody titers ≥1:5 at multiple time points (Days 14, 60, 120, and 160 post-final vaccination), measured by RFFIT.	14, 60, 120 and 160 days after last dose of vaccine.
Distribution GMTs of virus-neutralizing antibody titers in each group.	Geometric mean titers (GMTs) of rabies virus-neutralizing antibodies at Days 14, 60, 120, and 160 post-final vaccination, measured by RFFIT.	14, 60, 120 and 160 after last dose of vaccine.

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Sergio Recuenco, MD,MPH,DrPH, Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimated): January 7, 2010

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: rabies; rabies vaccine; purified cultured embryo chicken rabies vaccine
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Mononegavirales Infections; Rhabdoviridae Infections; Rabies; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CDC-NCEZID-5506; IND-13814 (Other Identifier: CDC); CDC-IRB 5506 (Other Identifier: CDC)